MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-25703-E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "during aspiration, gas was consistently retrieved, raising suspicion of a leak in the catheter body.For the sake of the patient's safety, a new catheter was replaced".No patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
It was reported that "during aspiration, gas was consistently retrieved, raising suspicion of a leak in the catheter body.For the sake of the patient's safety, a new catheter was replaced".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The customer provided one video showing a cvc catheter whilst inside the patient.The customer is observed aspirating the proximal extension line.No obvious defects or anomalies were observed.The customer also returned multiple components from a cvc kit including a lidstock.Signs of use in the form of biological material were observed.Visual analysis did not reveal any defects or anomalies on the returned catheter.Further analysis of the guide wire revealed kinking along the j-bend; however, as the customer makes no reference to this, it is assumed that this occurred in transit to the investigation facility.The catheter body length from the juncture hub to the distal tip measured 218mm, which is within the specification limits of 207mm-227mm per catheter product drawing.The catheter body outer diameter measured 2.39mm, which is within the specification limits of 2.39mm-2.49mm per catheter extrusion product drawing.The catheter was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".A lab inventory syringe filled with water was attached to all extension lines and flushed.No leaks or blockages were observed.The returned catheter was then tested per bs en iso 10555-1 section 4.7.1 (amrq-000071 rev.15) which states that there shall be no liquid leakage in the form of one or more falling drops when pressurized to 320 kpa for 30 seconds.The device was connected to a leak tester and pressurized to 300 kpa for 30 seconds with the distal end occluded.The extension lines were connected individually to the leak tester, and when pressurized, no catheter backflow or leaks were detected from any portion of the catheter.The ifu provided with the kit informs the user, "check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed".The ifu also states, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations".A device history record review was performed and no relevant findings were identified.The report of a leaking catheter body was not confirmed through complaint investigation of the returned sample.All lumens passed functional leak testing performed per iso 10555-1 and no evidence of leakage, backflow, or inter-lumen crossover was observed with any of the lumens.Based on the customer report and testing of the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23926176
• Report Number: 3006425876-2025-01208
• Device Sequence Number: 21166753
• Product Code: FOZ
• UDI-Device Identifier: 00801902102324
• UDI-Public: (01)00801902102324(11)250409(17)270325(10)71F25D0208(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F25D0208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown